FDA Device Surveillance to Tap Phone App

The Food and Drug Administration is creating a largely automated surveillance system to monitor safety of high-risk medical devices and has authorized a smartphone app for doctors to simplify reporting deaths and injuries to the agency.

The federal agency's efforts are designed to spot early on possibly dangerous flaws in high-risk medical devices like defibrillators, pacemakers, heart valves and joint implants. In recent years, when some of these medical devices have malfunctioned, it has taken months or even years before...